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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, nerve
510(k) Number K934426
Device Name NERVE INTEGRITY MONITOR-2 (NIM-2 XL)
Applicant
XOMED-TREACE, INC.
6743 SOUTHPOINT DRIVE NORTH
JACKSONVILLE,  FL  32216 -0980
Applicant Contact TERRY C MCMAHON
Correspondent
XOMED-TREACE, INC.
6743 SOUTHPOINT DRIVE NORTH
JACKSONVILLE,  FL  32216 -0980
Correspondent Contact TERRY C MCMAHON
Regulation Number874.1820
Classification Product Code
ETN  
Date Received09/10/1993
Decision Date 05/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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